Pilot Study : FreeStyle Libre Pro Flash Continuous Glucose Monitoring System in Subjects With Diabetes on HemoDIALsis

Diabetes Clinical Trial

— FSL DIAL  

Official title:

FreeStyle Libre Pro Flash Continuous Glucose Monitoring (CGM) System in Subjects With Diabetes on HemoDIALsis (FSL-DIAL Pilot Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04641650
• Other study ID #: FSL DIAL
• Status: Completed
• Start date: July 21, 2021
• Est. completion date: November 9, 2022

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Saint Joseph Saint Luc de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Continuous monitoring of glucose with a FreeStyle Libre pro sensor in diabetic and dialysis patients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: November 9, 2022
• Est. primary completion date: November 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diabetes without any change in treatment in the last 3 months

• Hemodialysis for > 3 months

• Recent laboratory HbA1c (< 15 days)

Exclusion Criteria:

• Patient does not show non-opposition

• Skin allergy to the sensor

• Sepsis / Acute anaemia

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Kidney Failure
• Renal Insufficiency

Locations

Country	Name	City	State
France	Centre Hospitalier Saint Joseph Saint Luc	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Saint Joseph Saint Luc de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between estimated Hba1c (or Glucose Management Index (GMI)) with FreeStyle Libre Pro sensor and laboratory Hba1c	Comparison between estimated HbA1c with 14 days of CGM data and laboratory HbA1c (routine blood test in hemodialysis) in each subject	At sensor removal (day 14)
Secondary	Time in glucose range	Percent (%) time in glucose range of =70 to =180 mg/dL (=3.9 to =10 mmol/L), obtained using professional continuous glucose monitoring (CGM)	At sensor removal (day 14)
Secondary	Time with Glucose < 70mg/dL	% time with glucose <70 mg/dL	At sensor removal (day 14)
Secondary	Time with Glucose > 180 mg/dL	% time with glucose >180 mg/dL	At sensor removal (day 14)
Secondary	Glucose total coefficient of variation (CV)	Glucose total CV (%)	At sensor removal (day 14)